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The goal of this clinical trial is to learn if a 12-week individualized aerobic training program helps manage inactive or mildly active inflammatory bowel disease (IBD) including Crohn's disease (CD) and ulcerative colitis (UC) in adult patients aged 18-65 years. It will also assess participant compliance and the safety of the training program. The main questions it aims to answer are:
Researchers will divide participants into two groups. One group will participate in the training program directly. The other group will first undergo a 12-week control intervention (i.e., standard treatment) before proceeding to the training program.
Participants will:
This study is a single-center, semi-crossover, randomized controlled trial. Patients will be consecutively screened from gastroenterology and inflammatory bowel disease clinics. After obtaining informed consent, they are randomly assigned in a 1:1 ratio, stratified by diagnosis (CD and UC). Group A immediately begins a 12-week individualized exercise training program, while Group B starts with a 12-week control intervention, consisting only of routine diagnosis and treatment, followed by the 12-week individualized exercise training. Comparisons are made for all patients before and after the exercise training and the control intervention.
Participants will be given different progressive individualized aerobic training schedules based on their baseline physical activity levels, with the exercise intensity increased every 4 weeks.
The implementation of the training program is based on telemedicine, utilizing a combination of methods including wearable devices, WeChat groups, and online form submissions to ensure quality control over the duration, intensity, and quality of the exercise training. Participants are required to wear fitness bands during the exercise training and use exercise software to record the exercise process, including duration, trajectory, maximal heart rate, and average heart rate. These data are promptly sent to the researchers upon completion of the exercise. Before the commencement of the exercise program, a dedicated researcher instructs the participants on how to use the bands to record the type of exercise, duration, and maximum heart rate, and then to timely fill in the exercise records on the online forms. Additionally, the researchers will discuss with the participants at the outset about the individualized exercise (including location, frequency, intensity, and type), the participants' motivation, expectations, and goals, as well as potential difficulties, aiming to enhance adherence to the training program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-week control intervention followed by 12-week aerobic exercise training | Active Comparator |
| |
| 12-week aerobic exercise training directly | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-week individualized aerobic exercise training | Behavioral | After enrollment, subjects directly participate in a 12-week aerobic exercise training program. The training plan provides individualized progressive aerobic training based on their baseline physical activity level measured by International Physical Activity Questionnaire (IPAQ), with the exercise intensity being increased every four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak oxygen uptake (pVO2) (in ml/kg/min) | Cardiorespiratory fitness measured by cardiopulmonary exercise testing (CPET) | At baseline and the end of intervention at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Crohn's Disease Activity Index (CDAI) | Measurement of patient-reported disease activity of CD participants. Higher scores mean higher activity. <150 indicates remission, 150~219 indicates mildly active. | At baseline, week 4, week 8 and the end of intervention at week 12 |
| Partial Mayo Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Zhou, M.D. | Contact | 8618395804423 | drzhouying07@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Affiliated Lihuili Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41490862 | Derived | Zhou Y, Liu H, Qian X, Zhang X, Xu F. Telemedicine-based individualised aerobic exercise training in Chinese adults with inactive or mildly active inflammatory bowel disease: study protocol for a single-centre, semi-crossover randomised controlled trial. BMJ Open. 2026 Jan 5;16(1):e103297. doi: 10.1136/bmjopen-2025-103297. |
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All IPD collected throughout the trial will be shared.
Start Date: Upon publication of this clinical trial. End Date: Five years following publication.
Who can access the data? Researchers who provide a methodologically sound proposal.
For what types of analysis? To achieve aims in the approved proposal. How can they access it? Proposals should be directed to drzhouying07@126.com. To gain access, data requestors will need to sign a data access agreement.
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|
| 12-week control intervention followed by 12-week aerobic exercise training | Behavioral | After enrollment, subjects first undergo a 12-week control intervention (i.e., routine treatment) and then participate in a 12-week aerobic exercise training program. The training plan provides individualized progressive aerobic training based on their baseline physical activity level IPAQ, with the exercise intensity being increased every four weeks. |
|
Measurement of Patient-reported disease activity of UC participants. Higher scores mean higher activity. 0~1 indicates remission. 2~4 indicates mildly active. |
| At baseline, week 4, week 8 and the end of intervention at week 12 |
| Concentration of fecal calprotectin | At baseline and the end of intervention at week 12 |
| Inflammatory Bowel Disease Questionnaire (IBDQ) | 32 questions grouped into four dimensions: bowel, systemic, social, and emotional. Scores range from 1 (poorest QoL) to 7 (best QoL). Higher scores indicate better QoL. | At baseline and the end of intervention at week 12 |
| Fatigue severity scale (FSS) | Minimum value is 9 and maximum value is 63 with higher scores indicating higher level of fatigue. | At baseline and the end of intervention at week 12 |
| Hospital Anxiety and Depression Scale (HADS) | Score of 0~21 with higher scores indicates higher level of anxiety and depression | At baseline and the end of intervention at week 12 |
| International Physical Activity Questionnaire (IPAQ) short form | A total IPAQ score is the sum of walking, moderate and vigorous metabolic equivalent of task (MET)-min/week. | At baseline and the end of intervention at week 12 |
| Body Mass Index (BMI) in kg/m^2 | At baseline and the end of intervention at week 12 |
| Waist circumference in cm | At baseline and the end of intervention at week 12 |
| Concentration of serum fasting glucose in mmol/L | At baseline and the end of intervention at week 12 |
| Concentration of serum albumin in g/L | At baseline and the end of intervention at week 12 |
| Concentration of serum cholesterol in mmol/L | At baseline and the end of intervention at week 12 |
| Concentration of serum triglyceride in mmol/L | At baseline and the end of intervention at week 12 |
| Concentration of serum fasting lipoprotein in mmol/L | At baseline and the end of intervention at week 12 |
| Concentration of serum uric acid in mmol/L | At baseline and the end of intervention at week 12 |
| Oxygen uptake at aerobic threshold (in ml/kg/min) | Oxygen uptake at aerobic threshold measured by CPET | at baseline and the end of intervention at week 12 |
| Peak oxygen uptake per heart rate (in ml/kg/min) | Peak oxygen uptake per heart rate measured by CPET | at baseline and the end of intervention at week 12 |
| Maximal heart rate (in bpm) | Maximal heart rate at peak measured by CPET | At baseline and the end of intervention at week 12 |
| Six-Minute Walk Test (in meters) | Maximum walked distance in meters conducted according to guideline | At baseline and the end of intervention at week 12 |
| Exercise Benefits/Barriers Scale | The Exercise Benefits/Barriers Scale (EBBS) will be used to assess participants' perceived benefits and barriers to exercise. | At baseline and the end of intervention at week 12 |
| Plasma C-reactive protein (mg/L) | At baseline and end of the intervention at week 12 |
| Plasma hemoglobin level (in g/L) | At baseline and end of the intervention at week 12 |
| Body fat percentage (%) | Body fat percentage measured via body composition analysis | At baseline and end of the intervention at week 12 |
| Skeletal muscle mass (kg) | Skeletal muscle mass (kg) measured via body composition analysis | At baseline and end of the intervention at week 12 |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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